A Phase 1/2 interventional study of ketamine and Fentanyl (IV) in Anesthesia, Sedation and Analgesia and Interventional Radiology, sponsored by CAMC Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by CAMC Health System · Phase 1/2, Interventional, and Treatment
This study wants to see if some interventional radiology (IR) procedures can be done without using general anesthesia. General anesthesia needs a lot of staff and equipment. It can also cause side effects. There are not enough anesthesia providers, which makes it harder to use for every procedure.
The researchers will test deep sedation with ketamine instead. They will start with 20 patients. If it works well and is safe, they may include up to 40 patients.
Patients will be asked to join the study before their procedure. The anesthesia team will be told ahead of time and will be ready to help if needed. The IR team will give the deep sedation and follow all safety rules.
The main goal is to finish the procedure without stopping early or switching to general anesthesia. The study will call this successful if fewer than 10% of cases fail. The researchers will also look at patient pain, patient satisfaction, any side effects, and how long recovery takes.
The long-term goal of this study is to improve patient care and healthcare system efficiency by reducing reliance on general anesthesia (GA) for interventional radiology (IR) procedures that have traditionally required anesthesiology support. GA is resource-intensive, associated with airway instrumentation and postoperative side effects, and increasingly constrained by national anesthesiology workforce shortages. This prospective, single-center, single-arm feasibility pilot will evaluate IR-led ketamine-based deep sedation in an initial cohort of 20 patients undergoing IR procedures that would ordinarily be performed under GA, with prespecified expansion to up to 40 participants if early feasibility and safety criteria are met. Eligible patients will be approached prior to their procedure, and the anesthesiology service will be formally consulted in advance and available for immediate escalation if needed. Deep sedation will be administered by the IR sedation team under institutional deep sedation privileges and monitoring standards. The primary outcome is feasibility: successful completion of the planned procedure without failure, where failure is defined as procedure abortion due to inadequate sedation or intolerance, or escalation to anesthesiology takeover and/or conversion to GA. A prespecified feasibility threshold of ≤10% failure will be used. Secondary outcomes include patient-reported pain and satisfaction, peri-procedural adverse events, and recovery duration.
CAMC Health System is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants will include adults (≥18 years) scheduled to undergo image-guided IR procedures for which general anesthesia would ordinarily be requested. These may include, but are not limited to, image-guided percutaneous spine biopsy, biliary procedures, ablations, and embolizations. These may also include less invasive procedures on patients who previously did not tolerate light or moderate sedation. Participants receive deep sedation led by the Interventional Radiology team using a combination of ketamine, midazolam, and fentanyl. The sedation regimen follows guidelines set forth in other procedures. An initial intravenous bolus of 1-2 mg midazolam, followed by 30-50 mg intravenous ketamine, with additional 10-30 mg ketamine boluses administered every 10-15 minutes as needed, not to exceed a maximum dose of 2 mg/kg. Boluses of 0.5-1 mg intravenous midazolam and 25-50 mcg intravenous fentanyl will be administered every 10-15 minutes as needed to achieve deep sedation.
Drug: ketamine · Drug: Fentanyl (IV) · Drug: Midazolam
Ketamine will be administered as follows: initial intravenous bolus of 30-50 mg intravenous ketamine, with additional 10-30 mg ketamine boluses administered every 10-15 minutes as needed, not to exceed a maximum dose of 2 mg/kg.
25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.
Midazolam will be administered as follows: an initial intravenous bolus of 1-2 mg midazolam followed by maintenance boluses of 0.5-1 mg intravenous midazolam as needed to achieve deep sedation.
Aim 1 - Feasibility
For Aim 1, feasibility will be assessed by calculating the proportion of procedures completed without failure, where failure is defined as procedure abortion due to inadequate sedation or patient intolerance, or escalation to anesthesiology takeover and/or conversion to general anesthesia. The observed failure proportion will be reported with exact (Clopper-Pearson) 95% confidence intervals. Feasibility will be interpreted relative to the prespecified threshold of ≤10% failure.
Time frame: From enrollment in the study immediately before the procedure to the completion of the patient satisfaction survey given after surgical recovery, within 2-hours post-op. Enrollment, procedure, and survey are completed in the same day.
Patient-Reported Pain
Pain will be assessed using the validated 10-point Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents worst imaginable pain. The study coordinator will document pre-procedure pain and post-procedure pain in the immediate recovery period. If a participant reports no recall of the procedure, this will be recorded as "no recall of pain/procedure" rather than imputing a numeric score. All pain scale measurements occur the same day as the procedure, and there are no other longitudinal measurements.
Time frame: Pre-procedure (baseline; immediately before procedure) and post-procedure (immediately after recovery period; within 2 hours post-op).
Patient Satisfaction
Patient satisfaction will be assessed using a modified Heidelberg peri-anesthetic questionnaire (18 questions) administered in the recovery area prior to discharge or return to the inpatient unit. Questions 1-16 are rated on a scale from 1 (Strongly Disagree) to 4 (Strongly Agree). Question 17 asks if the patient would, in the future, have "more sedation," "same sedation," or "less sedation." Question 18 asks the patient to rate their level of pain on a scale from 0 (no pain) to 10 (worst possible pain).
Time frame: Questionnaire given after recovery from procedure (within 2 hours post-op).
Recovery Duration
Recovery duration will be defined as the time from procedure completion to discharge from the procedural recovery area or return to the inpatient unit, reflecting clinically meaningful recovery rather than anesthetic emergence alone.
Time frame: Immediately post-procedure to discharge from recovery area (within 2 hours post-op).
Sedation-Related Adverse Events
Sedation-related adverse events will be prospectively documented and will include: * Hypotension or hypertension requiring intervention * Oxygen desaturation \<90% * Need for airway intervention * Escalation to anesthesiology takeover and/or conversion to general anesthesia * Administration of reversal agents * Post-procedural nausea, vomiting, or hallucinations not responsive to medications Procedure-related adverse events will include bleeding, pneumothorax, infection, and other complications classified according to Society of Interventional Radiology (SIR) Standards of Practice. Vital signs, including lowest oxygen saturation and lowest and highest blood pressure during the procedure, will be recorded. This outcome is for the single day in which the procedure occurs. No pre-procedural or longitudinal data is applicable.
Time frame: The procedure begins and finishes in one day. Adverse events that occur during the procedure, immediately after, and after recovery (within 2-hours post-procedure) will be recorded.
Plan to share: No — The data obtained from this study relies on sedation success, patient opinion surveys, and pain scales. The informed consent form signed by participants does not include a provision for the sharing of individual participant-level data with outside researchers. Data disclosure is limited to study personnel, hospital staff, and regulatory agencies. Data that is relevant to the outcomes of the study, as well as detailed statistical methods, will be included in publications that use the data gathered from this trial.
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Studies of the drugs tested here: Ketamine · Fentanyl · Midazolam
Agnosia
CAMC Health System